Lab & Testing Services
Below is a table of our testing services including chemistry and microbiological tests. Contact our support team for the most up-to-date information on our testing services, and for assistance with submitting a sample to our lab. We look forward to serving you.
|ScanRDI® Sterility Test Protocol
A rapid microbiological sterility test that utilizes the technology of fluorescent labeling and laser scanning to detect bacteria, mold, yeast and fungi.
|2 business days||$250|
|ScanRDI Method Suitability Test (required on file)||7 business days||$1,500|
|Anti-Microbial Effectiveness (AME) Test (USP <51>)
Demonstrates efficacy of anti-microbial preservatives in multi-dose containers.
|USP <51> Method Suitability Test (required on file)
|Microbial Enumeration Test (USP <61>)
Identifies the presence of microorganisms within a non-sterile compound or product.
|7 business days||$195|
|Bioburden Testing – NEW||7 business days||$1,000|
|USP <61>/<62> Method Suitability Test (required on file)||7 business days||$750|
|Objectionable Organisms (USP <62>)
Identifies the exact microorganism within a non-sterile compound or product.
|7 business days||$99/organism|
|USP <61>/<62> Method Suitability Test (highly recommended)||7 business days||$750|
|Sterility Test (USP <71>)|
|Identify bacteria, mold, yeast and fungi with two media at two separate temperatures.||14-18 business days||$99|
|Daily reading||14-18 business days||$299|
|USP <71> Method Suitability Test (required on file)||7 business days||$395|
Microbial ID, Media Fill, etc. — please call 800.745.8916
|Turbidimetric Bacterial Endotoxin Test System (USP <85>)
Configured to compensate for beta-glucan interferences. All tests include a positive endotoxin spike to detect endotoxin inhibition/enhancement effects.
|2 business days||$99|
|USP <85> Method Validation||5 business days||$450|
|Particulate Count Test (USP <788>)
Ensures that solutions are free from particulate matter that cannot be quantitated by chemical analysis alone.
|5 business days||$150|
|Container Closure Integrity Test (USP <1207>)
Evaluates the container closure system and its ability to maintain integrity of its microbial barrier.
|Utilizing the “Pressure Decay” Method||5 business days||$500|
|Utilizing the “Dye Ingress” Method||5 business days||Call for Pricing|
|Spectroscopic Identification Tests (USP <197>)
Identification by IR
|5 business days||Call for Pricing|
|Identification by UV||5 business days||Call for Pricing|
|Total Organic Carbon (USP <643>)
An indirect measure of organic molecules present in pharmaceutical waters measured as carbon.
|7-10 business days||Call for Pricing|
|Chromatography (USP <621>)
Multistage separation methods in which the components of a sample are distributed between two phases, of which one is stationary and the other is mobile.
|Varies||Call for Pricing|
Uses the advanced HPLC/UHPLC and Spectrographic instrumentation. Protocols have been developed based on USP <621> and <851> methodology.
Non-solution samples (capsules, gels, suspensions, creams, animal treats, powder aliquots, suppositories, troche, tablets, etc.)
Delays in analysis and/or additional costs may occur if formula worksheet is not submitted, or if Eagle does not have current developed protocols for the active ingredient(s) present in the sample.
|1-3 Actives||4 business days|
|4+ Actives||7 business days|
|Solid dosage forms: 1-3 Actives||5 business days|
|Solid dosage forms: 4+ Actives||7 business days|
|HCG||7 business days||Call for Pricing|
|Pure API Assay||$500|
View Minimum Sample Requirements (PDF)
An analytical process that provides evidence on how the concentration and quality of a drug substance or drug product varies over a given time under the influence of a variety of environmental factors, such as temperature, humidity, and light.
Quote provided upon request. Call the Eagle Client Care Team at 832.295.1276
ADDITIONAL TESTING SERVICES
We offer additional testing services not listed on this document. Call the Eagle Client Care Team at 832.295.1276 for more information.
*Testing begins 1 business day after sample is received
*RUSH Service available for double the regular test price.
Please note: A $50 cancellation fee will be assessed if cancellation is requested after samples have arrived at our facility. If testing has been initiated, the full price of the test will be charged.
All pricing in U.S Dollars and subject to change at any time.
Would your sterile compounding process pass an FDA inspection? In order to fully comply with USP <797>, a compounding pharmacy creating sterile preparations must develop its own formal quality assurance (QA) program. The characteristics of a QA program require the consideration of environmental testing and preparation verification results, with the recommended testing method outlined by USP <71>.
Because the compendial method of testing takes 14 to 18 days to complete, it is extremely limiting in the compounding industry. A sterile compound with a standard 30 day expiry will lose approximately half of its shelf life due to sterility testing. This delay may discourage compounders from developing or adhering to a QA program, leaving them at risk of failing an FDA inspection.
However, there is a faster way to comply with USP <797> and ensure your patients are receiving quality compounds. The ScanRDI Sterility Test Protocol is an FDA-accepted alternative to the official compendial sterility test method. ScanRDI rapidly detects viable microbial cells down to one microorganism without the need for growth or cell multiplication. This removes the extended incubation period included in the USP <71> test method, so results are ready in just one day.
According to USP General Notices, alternate testing methods may be used if they can be shown to provide equivalent or better results. ScanRDI uses the same sampling protocols as USP <71>, detects all of the standard USP organisms and has been shown to provide consistent and reliable results.1 Additionally, ScanRDI fulfills the method suitability requirement as outlined in USP <1223>. A suitability test is performed on every unique drug formula sample submitted for ScanRDI testing. If the suitability of a compound does not pass this test, Eagle will inform the compounding pharmacist that it was incompatible with the ScanRDI method.
Want to learn more? Contact us at 800-745-8916, today.
1 Smith, R., Von Tress, M., Tubb, C., & Vanhaecke, E. (2010). Evaluation of the ScanRDI as a Rapid Alternative to the Pharmacopeial Sterility Test
Method: Comparison of the Limits of Detection. PDA Journal of Pharmaceutical Science and Technology, 64, 356-363
USP <51> Antimicrobial Effectiveness:
Sterile articles packaged in multi-dose containers must be free of microorganisms throughout their entire shelf-life. Due to the potential for the introduction of microorganisms through the repeated withdrawal of individual doses, sterile products that are packaged in mutli-dose containers should contain an antimicrobial preservative. However, the concentration of an added antimicrobial preservative can be kept to a minimum if the ingredients of the compounded formulation possess an intrinsic antimicrobial activity. Antimicrobial effectiveness, whether inherent in the product or as a result of an antimicrobial preservative, must be demonstrated through USP <51> antimicrobial effectiveness testing.
USP <61> Microbial Enumeration Test:
As the presence of microorganisms in nonsterile preparations has the potential to reduce and/or inactivate therapeutic activity and adversely affect the health of patients, compounders are required to ensure that nonsterile preparations have a low bioburden that complies with established specifications for microbiological quality as outlined in USP <61>. USP <61> Microbial Enumeration tests provide a quantitative evaluation of a product’s microbial content to demonstrate compliance with established specifications.
USP <62> Tests for Specific Microorganisms:
Table 1 in USP <1111> sets acceptance criteria for the presence of certain microorganisms in a nonsterile preparation based on its route of administration. The presence of these objectionable pathogens and microorganisms cannot exceed the acceptance criteria outlined in Table 1. USP <62> testing is designed to demonstrate compliance with these requirements by quantifying the presence of specified microorganisms.
USP <71> Sterility Testing:
USP <71> outlines the compendial requirements for sterility testing that must be followed in order to be able to claim that the results of the test provide evidence that the product is sterile.
USP <71> Method Suitability Testing:
USP <71> Method Suitability Testing (MST) must be performed prior to being able to claim that the results of a USP <71> sterility test provide evidence of a preparation’s sterility. Method Suitability Testing only needs to be completed once for each compounded formulation, and consists of two parts: i) a suitability test that confirms that the growth media used for sterility testing supports the growth of certain microorganisms and ii) a validation test that demonstrates that no components of the compounded preparation inhibit microbial growth.
USP <85> Bacterial Endotoxin Testing:
As bacterial endotoxins can pose health and safety hazards to patients, USP <85> requires bacterial endotoxin testing to detect and quantify the presence of endotoxins from Gram-negative bacteria in sterile compounds. To assure patient safety, the quantity of bacterial endotoxins may not exceed threshold limits defined in USP <85>. For each bacterial endotoxin test, inhibition validation testing is performed. This testing confirms that there are no components of the formulation that will interfere with the bacterial endotoxin test and that the testing used is sensitive enough to provide meaningful, accurate data.
USP <788> Particulate Count:
Solutions must be essentially free from observable particulate matter. Due to the small amount of material and the heterogenous composition that particulate matter represents, it cannot be quantitated by chemical analysis alone.
USP <1207> Container-Closure Integrity Testing:
USP <1207> container-closure integrity testing demosntrates the ability of the container-closure system to maintain the integrity of its microbial barrier throughout the entire shelf-life of a product. Eagle utilizes a pressure decay to test container-closure integrity, which is one of the deterministic methods recommended by USP <1207>. As sterility is an event-related occurrence, container-closure integrity testing is performed to support the claim that the sterile containers in which the preparation is packaged are capable of maintaing the sterility of the product throughout its shelf life.
USP <197> Spectroscopic Identification Tests:
Identification by IR USP <197>: This test provides conclusive evidence of the identity of a substance using infrared absorption spectrums compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.
Identification by UV USP <197>: This test provides the identity of a substance using ultraviolet absorption spectrums compared to a USP reference standard. Conformance with both IR absorption and UV absorption test specifications, as called for in a large proportion of compendial monographs, leaves little doubt, if any, regarding the identity of the specimen under examination.
USP <643> Total Organic Carbon:
Total Organic Carbon (TOC) is an indirect measure of organic molecules present in pharmaceutical waters measured as carbon. Organic molecules are introduced into the water from the source water, purification and distribution system materials, biofilm growing in the system, and the packaging of sterile and nonsterile waters. TOC can also be used as a process control attribute to monitor the performance of unit operations comprising the purification and distribution system.
USP <621> Chromatography:
USP <621> Chromatographic separation techniques are multistage separation methods in which the components of a sample are distributed between two phases, of which one is stationary and the other is mobile. The analytical chromatography methods Eagle utilizes are designed to determine the concentration of the active ingredient(s) in a compounded preparation. Testing protocols are developed based on guidelines delineated in USP <621> Chromatography and are validated according to USP <1225> Validation of Compendial Procedures and ICH Guidelines. The customer is notified immediately of any sample that does not test within acceptable limits.
Potency tests are designed to determine the concentration of the active ingredient(s) in a compounded preparation. This test should be conducted to demonstrate that the potency of the active ingredient(s) remain within product specifications for the course of a preparation’s shelf-life. When testing for potency, the concentration of active ingredient is measured using a reference standard. Eagle performs potency tests by using state of the art instrumentation, and endeavors to stay ahead of technological advancements to provide the best service to our customers.